Clinical Trials /

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

NCT04752332

Description:

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
  • Official Title: eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

Clinical Trial IDs

  • ORG STUDY ID: 17384
  • SECONDARY ID: I3Y-MC-JPCW
  • SECONDARY ID: 2020-004035-24
  • NCT ID: NCT04752332

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib Plus (+) Endocrine Therapy (ET)
Standard Adjuvant ETAbemaciclib Plus (+) Endocrine Therapy (ET)
PlaceboPlacebo + ET

Purpose

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

Trial Arms

NameTypeDescriptionInterventions
Abemaciclib Plus (+) Endocrine Therapy (ET)ExperimentalAbemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
  • Abemaciclib
  • Standard Adjuvant ET
Placebo + ETActive ComparatorPlacebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.
  • Standard Adjuvant ET
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  Have confirmed HR+, HER2+ in initial diagnostic tissue, early invasive breast cancer
             without evidence of disease recurrence or distant metastases

          -  Have undergone definitive surgery of the primary breast tumor(s)

          -  Have tumor tissue from breast (preferred) or lymph node

          -  Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or
             adjuvant setting per standard of care therapy

          -  Have completed at least nine months and up to one year of standard HER2-targeted
             therapy without evidence of disease recurrence (neoadjuvant/adjuvant combined
             duration)

          -  Have received one of the following eligible HER2-targeted adjuvant regimens AND be
             randomized within 12 weeks of completing the regimen:

               -  For participants treated with neoadjuvant therapy (chemotherapy with
                  trastuzumab-based therapy): Single agent adjuvant ado-trastuzumab emtansine or

               -  For participants not treated with neoadjuvant therapy: Adjuvant pertuzumab with
                  trastuzumab

          -  Have high risk disease, defined by one of the following:

               -  For participants treated with neoadjuvant therapy (as defined above):
                  Pathologically detected axillary nodal disease in the surgical specimen

               -  For participants not treated with neoadjuvant therapy: Axillary node positive
                  disease meeting one of the following criteria:

                    -  Pathological tumor involvement in greater than or equal to (≥) four
                       ipsilateral axillary lymph nodes OR

                    -  Pathological tumor involvement in one to three ipsilateral axillary lymph
                       node(s) and at least 1 of the following criteria:

          -  Histological Grade 2 or Grade 3

          -  Primary invasive tumor size ≥5 centimeters determined pathologically

        Exclusion Criteria:

          -  Have breast cancer with any of the following features:

               -  Disease recurrence or distant metastatic disease (including contralateral
                  axillary lymph nodes)

               -  Lymph node-negative status

               -  Pathological complete response from any prior systemic treatments for early
                  breast cancer

               -  Inflammatory breast cancer

          -  Have other medical conditions including:

               -  Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ [DCIS]
                  treated by locoregional therapy alone ≥5 years ago; contralateral DCIS treated by
                  locoregional therapy at any time)

               -  Other cancer being treated and/or not in complete remission within the last 5
                  years (Exceptions: Appropriately treated non-melanomatous skin cancer or
                  carcinoma in situ of cervix, bladder, or colon)

               -  Females who are pregnant or lactating

               -  History of venous thromboembolism

               -  Other serious medical conditions

          -  Have previously received treatment with:

               -  Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor

               -  Prior adjuvant treatment with immunotherapy, tucatinib, neratinib,
                  investigational HER2 directed therapy, or trastuzumab deruxtecan for treatment of
                  breast cancer

               -  Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for
                  breast cancer prevention (without diagnosis of breast cancer)

               -  Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard
                  of care therapy for their breast cancer at study enrollment

               -  Bone-targeting agents prescribed as cancer modifying treatment agent (It is
                  permitted as treatment for prevention of osteoporosis)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Invasive Disease Free Survival (IDFS)
Time Frame:Randomization to Recurrence or Death from Any Cause (up to 10 Years)
Safety Issue:
Description:IDFS as defined by the STEEP System

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Randomization to Death from Any Cause (up to 10 Years)
Safety Issue:
Description:OS
Measure:Distant Relapse-Free Survival (DRFS)
Time Frame:Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Safety Issue:
Description:DRFS
Measure:Percentage of Participants with Central Nervous System (CNS) Metastases as First Site of Disease Recurrence
Time Frame:Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Safety Issue:
Description:Percentage of Participants with CNS Metastases as First Site of Disease Recurrence
Measure:Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
Time Frame:Cycle 1 up to end of Year 4
Safety Issue:
Description:EORTC QLQ-C30 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Measure:Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
Time Frame:Cycle 1 up to end of Year 4
Safety Issue:
Description:The EQ-5D is a self-administered questionnaire that participants complete to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 5 (no problem, slight problems, moderate problems, severe problems, and extreme problems/unable to, respectively). These combinations of attributes were converted into a weighted Health State Index score; the possible values for the Health State Index score range from less than 0 (0 equals health state of "dead"; severe problems in all 5 dimensions) to 1.0 (full health; no problem in any dimension). Higher score indicates better health state.
Measure:Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
Time Frame:Day 1 of Cycles 1-3 (Cycle = 28 days)
Safety Issue:
Description:PK: Mean Steady State Concentrations of Abemaciclib

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Last Updated

April 6, 2021